Pfizer to supply COVID-19 pill to low-income countries via licensing deal

On Tuesday, U.S. pharmaceutical giant Pfizer announced that it had signed a new licensing agreement with the Medicines Patent Pool (MPP), a United Nations–backed organization, that will help supply Pfizer’s antiviral COVID-19 pill to lower- and middle-income countries.

Earlier this month, Pfizer announced that its COVID-19 pill reduced the risk of hospitalization and death among COVID-19 patients by 89%, fueling hope that the drug will give the world another defense against the worst effects of the coronavirus.

Pfizer’s new partnership with the MPP opens the door for Pfizer to supply its COVID drug to the world’s poorest and most vaccine-starved countries. The licensing agreement authorizes the MPP to facilitate production of the pill by granting “sublicenses” to qualified generic drug manufacturers and distribute doses based on need, according to a statement.

“We must work to ensure that all people—regardless of where they live or their circumstances—have access to these breakthroughs, and we are pleased to be able to work with MPP to further our commitment to equity,” Albert Bourla, Pfizer CEO, said in the statement.

Pfizer’s COVID-19 pill, called Paxlovid, is given to patients at high risk of developing severe infections after an initial COVID diagnosis. An interim trial found that 0.8% of patients who received Paxlovid after getting diagnosed with COVID-19 were hospitalized after 28 days. For patients who received a placebo, 7% required hospitalization after 28 days.

Pfizer’s pill has not been approved by the U.S. Food and Drug Administration or any other health authority, and the company has not yet released detailed data from its interim study. Still, Bourla said, Pfizer plans to submit its FDA application before Thanksgiving and expects to have 21 million doses ready to deploy by the first half of 2022. Pfizer noted it has ceased enrolling new patients in its clinical trial owing to the “overwhelming efficacy” demonstrated and plans to submit documentation to the FDA for approval as soon as possible.

Pfizer’s commitment to equitable access to its new COVID-19 treatment comes as the firm reported strong revenue this month on the back of its highly effective mRNA COVID-19 vaccine that it developed with Germany’s BioNTech. Pfizer reported in early November that through the third quarter of 2021 it had earned $24.3 billion in revenue from its COVID-19 vaccine. It expects its 2021 COVID-19 vaccine revenue to rise to $36 billion by the end of the year.

Pfizer has faced criticism for earning such profits during the pandemic while much of the world’s poorest countries continue go without vaccines.

“It is obscene that just a few companies are making millions of dollars in profit every single hour, while just 2% of people in low-income countries have been fully vaccinated against coronavirus,” Maaza Seyoum, African coordinator of the People’s Vaccine Alliance, said in a press release on Tuesday. “Pfizer, BioNTech, and Moderna have used their monopolies to prioritize the most profitable contracts with the richest governments, leaving low-income countries out in the cold.”

The World Health Organization, the U.S., and dozens of countries have backed a call for the World Trade Organization to drop manufacturers’ exclusive intellectual property rights to COVID-19 vaccines. Supporters of a waiver say it could help ramp up vaccine production and allow lower-income countries to access the jabs.

Bourla opposes waiving intellectual property rights for COVID-19 vaccines. He argues that doing so would “create more problems” by potentially disrupting the supplies of raw materials.

But with its oral antiviral pill, Pfizer appears to be taking a different path in providing its formula to generic manufacturers.

In October, Merck made a similar decision to allow generic manufacturers to produce its antiviral pill, which trials show reduces the risk of hospitalization and death among COVID-19 patients by 50%. The U.S. drugmaker is also partnering with the MPP to send Merck’s recipe to a network of global manufacturers.

Twenty-four leading pharmaceutical manufacturers around the world have committed to an MPP pledge to collaborate on producing COVID-19 treatments like Pfizer’s pill for low-income countries. One of the signatories of the MPP’s pledge, Indian generic drugmaker Dr. Reddy’s, said this week that it’s willing to produce Pfizer’s antiviral pill once it gets approved in the U.S. Dr. Reddy’s did not specify what it might charge for the drug, but said it does not expect to make profits from selling antiviral treatments.

“[Pfizer’s licensing agreement with the MPP] is so important because, if authorized or approved, this oral drug is particularly well suited for low- and middle-income countries,” Charles Gore, executive director of MPP, said in a statement.